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Clinical Trials/NCT04062864
NCT04062864
Completed
Not Applicable

Validity of Pupil Diameter for Pain Monitoring During General Anesthesia in Children : a Prospective Observational Study

Seoul National University Hospital1 site in 1 country35 target enrollmentAugust 21, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, General
Sponsor
Seoul National University Hospital
Enrollment
35
Locations
1
Primary Endpoint
Pupil diameter
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

This study evaluates the validity of pupil diameter as an indicator of pain during surgery under general anesthesia.

Detailed Description

Pupil diameter is known to be strongly correlated with sympathetic tone. During surgery under general anesthesia, there is no standardized means of pain assessment. As pain activates sympathetic nervous system, we hypothesized that pupil diameter can be a marker for pain during surgery.

Registry
clinicaltrials.gov
Start Date
August 21, 2019
End Date
July 24, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hee-Soo Kim

Professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

  • Children undergoing surgery under general anesthesia with total time of less than two hours

Exclusion Criteria

  • Children whose parent or legal guardian declined to enroll
  • Any use of opioids during surgery
  • History of hypersensitivity to any anesthetic agents
  • Any medication that can affect sympathetic nervous activity
  • Presence of underlying ophthalmologic disease

Outcomes

Primary Outcomes

Pupil diameter

Time Frame: From start of anesthesia to end of anesthesia

Pupil diameter before and after painful stimuli (skin incision, train-of-four stimulation)

Secondary Outcomes

  • Bispectral index(From start of anesthesia to end of anesthesia)
  • Pleth variability index(From start of anesthesia to end of anesthesia)

Study Sites (1)

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